StabiliT VP Vertebroplasty System - Orthopaedic cement preparation/delivery kit

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Merit Medical Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
322675

Public Summary

Summary for ARTG Entry:

322675

Merit Medical Australia Pty Ltd - StabiliT VP Vertebroplasty System - Orthopaedic cement

preparation/delivery kit

ARTG entry for

Medical Device Included Class IIb

Sponsor

Merit Medical Australia Pty Ltd

Postal Address

63 Wells Road,Chelsea Heights, VIC, 3196

Australia

ARTG Start Date

4/09/2019

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Merit Medical Systems Inc

1600 West Merit Parkway

South Jordan, UTAH, 84095

United States Of America

Products

1. StabiliT VP Vertebroplasty System - Orthopaedic cement preparation/delivery kit

Product Type

Medical device system

Effective date

4/09/2019

GMDN

45253 Orthopaedic cement preparation/delivery kit

Intended purpose

The StabiliT VP Vertebroplasty System is intended for percutaneous delivery of StabiliT Bone Cement.

The StabiliT Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a

vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from

osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 05:10:17 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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